Bausch + Lomb Receives FDA Approval of LOTEMAX® (loteprednol etabonate ophthalmic gel) 0.5% Gel Drop Formulation
New Gel Formulation of Loteprednol Corticosteroid Indicated
for Post Ocular Surgery Inflammation and Pain
MADISON, N.J. — Bausch + Lomb, the global eye health company, today announced that the U.S. Food and Drug Administration (FDA) has approved the company's New Drug Application (NDA) for LOTEMAX® (loteprednol etabonate ophthalmic gel) 0.5 percent gel drop formulation, a new topical corticosteroid formulation in its line of loteprednol ophthalmic products. LOTEMAX Gel is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery.
About LOTEMAX Gel
LOTEMAX Gel is a topical ocular treatment for post-operative inflammation and pain in patients who have had ocular surgery. Loteprednol etabonate (LE), the active ingredient in LOTEMAX Gel, was first approved as an ocular anti-inflammatory agent by the FDA in 1998. In 2011, the total U.S. market for ophthalmic steroids was $260 million with more than six million prescriptions written each year.
Dosage and Administration
Apply one or two drops of LOTEMAX Gel into the conjunctival sac of the affected eye four times daily beginning the day after surgery and continuing throughout the first two weeks of the post-operative period.
Dosage Forms and Strengths
Topical ophthalmic gel: loteprednol etabonate ophthalmic gel 0.5 percent.
Important Safety Information about LOTEMAX Gel
Warnings and Precautions
About Bausch + Lomb
Bausch + Lomb is one of the best-known and most respected healthcare companies in the world. Its core businesses include contact lenses and lens care products, ophthalmic surgical devices and instruments, and ophthalmic pharmaceuticals. Founded in 1853, the company is headquartered in Rochester, N.Y., and employs more than 11,000 people worldwide. Its products are available in more than 100 countries. More information is available at www.bausch.com.
®/™ are trademarks of Bausch & Lomb Incorporated or its affiliates.
© 2012 Bausch & Lomb Incorporated.
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